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The purpose of the study is to assess safety, tolerance, pharmacokinetic, and pharmacodynamics of single doses of ACE-2494 in healthy postmenopausal women.
Full description
Subjects will be evaluated for study inclusion/exclusion criteria during the screening period (within 4 weeks prior to Day -1) and eligible subjects who have signed the informed consent form (ICF) will be enrolled and treated with study drug (ACE-2494 or placebo) on Day 1. Subjects will be randomized (3:1, ACE-2494: placebo) to receive one dose of either ACE-2494 or placebo, respectively, on Day 1.
The primary objective of the study is to evaluate the safety and tolerability of single ascending doses of ACE-2494 in healthy postmenopausal women. The secondary objectives are to characterize the pharmacokinetic (PK) profile and pharmacodynamic (PD) effects, including serum biomarkers, fat, lean, and bone mass (DXA), muscle volume and intramuscular fat fraction (MRI).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Postmenopausal women, with menopause defined by follicle stimulating hormone (FSH) level > 40 IU/L and either 12 months of spontaneous amenorrhea or at least 6 months post-surgical bilateral oophorectomy and/or hysterectomy
Age 45-75 years
Body mass index (BMI) 18.5-32.0 kg/m2
Clinical laboratory values that meet the following criteria prior to dosing on Day 1:
Ability to adhere to the study visit schedule/procedures, and to understand and comply with protocol requirements
Signed written informed consent
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
48 participants in 6 patient groups
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Data sourced from clinicaltrials.gov
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